Heating/cooling system for indwelling heat exchange catheter

ABSTRACT

A cooling system for an indwelling heat exchange catheter includes a heat exchange bath that is configured to receive a conduit that carries saline to and from the catheter. A heating/cooling fluid is in the bath and exchanges heat with the saline. The heating/cooling fluid flows through a heat exchanger that includes a refrigerant and two variable speed DC compressor for removing heat from the refrigerant. A gear pump circulates the working fluid to and from the catheter and is removably engaged with a pump support platform.

RELATED APPLICATIONS

The present invention is a Continuation-in-Part of the U.S. patentapplication Ser. No. 09/965,560 filed on Sep. 25, 2001. This applicationclaims priority from U.S. provisional patent application Ser. No.60/492,818, filed Aug. 6, 2003.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and apparatus forexchanging heat with the body of a patient.

2. Description of the Related Art

It has been discovered that the medical outcome for a patient sufferingfrom severe brain trauma or from ischemia caused by stroke or heartattack is improved if the patient is cooled below normal bodytemperature (37° C.). Furthermore, it is also accepted that for suchpatients, it is important to prevent hyperthermia (fever) even if it isdecided not to induce hypothermia. Moreover, in certain applicationssuch as post-CABG surgery, it might be desirable to rewarm a hypothermicpatient.

As recognized by the present invention, the above-mentioned advantagesin regulating temperature can be realized by cooling or heating thepatient's entire body. Moreover, the present invention understands thatsince many patients already are intubated with central venous cathetersfor other clinically approved purposes anyway such as drug delivery andblood monitoring, providing a central venous catheter that can also coolor heat the blood requires no additional surgical procedures for thosepatients. However, single purpose heat exchange catheters such as aremade by Innercool Therapies of San Diego, Calif. and Radiant Medical ofPortola Valley, Calif. can also be less optimally used.

Regardless of the particular catheter used, it is clear that heat mustbe removed from or added to the coolant that flows through the catheter.As recognized herein, it is desirable that a heat exchange system for aheat exchange catheter consume minimal energy and space. Small size isdesired because space is often at a premium in critical care units.Moreover, as also recognized herein, for patient comfort it is desirablethat such a heat exchange system generate a minimum amount of noise. Asstill further understood by the present invention, it is desirable thatthe heat exchange system be easy to use by health care personnel, andprovide for monitoring systems and convenient temperature control. U.S.Pat. No. 6,146,411, incorporated herein by reference, discloses one suchheat exchange system. It is the object of the present invention to stillfurther address one or more of the above-noted considerations.

SUMMARY OF THE INVENTION

A heat exchange system for an indwelling heat exchange catheter includesa heat exchange bath that is configured to receive a conduit thatcarries working fluid to and from the catheter. A heating/coolant fluidis disposed within the bath to exchange heat with the working fluid. Theheating/coolant fluid flows through a heat exchanger that includes arefrigerant and two or more compressors that are connected in parallelto each other, Moreover, a heating/coolant fluid pump circulates theheating/coolant fluid between the heat exchanger and the heat exchangebath.

In a preferred embodiment, the compressors are variable speed directcurrent (DC) compressors. Also, a positive displacement gear pumppreferably pumps the working fluid, e.g., saline, to and from thecatheter. In a preferred embodiment, the pump is removably engaged witha motor.

In another aspect of the present invention, a heat exchange system foran indwelling heat exchange catheter includes a heat exchange bath thatis configured to receive a conduit that carries working fluid to andfrom the catheter. A pump communicates with the conduit and pumps theworking fluid to and from the catheter.

In yet another aspect of the present invention, a fluid pump assemblyincludes a pump support platform. A pump is removably engaged with thepump support platform. In this aspect, the pump pumps working fluid toand from an intravascular catheter.

In still another aspect of the present invention, a heat exchange systemfor an indwelling heat exchange catheter includes a heat exchange baththat is configured to receive a conduit that carries working fluid toand from the catheter. In this aspect of the present invention, a flowdetector communicates with the conduit and detects when working fluid isflowing through the conduit.

In yet still another aspect of the present invention, a fluid flowdetector includes

a clear housing and a paddle wheel that is rotatably disposed within thehousing. The fluid flow detector further includes three infraredtransmitter/receiver light emitting diode pairs. Each infraredtransmitter/receiver light emitting diode pair establishes a signal paththrough the housing.

The details of the present invention, both as to its construction andoperation, can best be understood in reference to the accompanyingdrawings, in which like numerals refer to like parts, and which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic diagram of a heating/cooling system in accordancewith the present invention;

FIG. 2 is a cross-sectional view of a heat exchange bath with the waterglycol return line and level detector omitted for clarity;

FIG. 3 is a cross-sectional view of a fluid level detector;

FIG. 4 is a detailed cross-sectional view of a chiller/heater;

FIG. 5 is a flow chart of the overall operation logic of the presentinvention;

FIG. 6 is a flow chart of the linear mode operation logic of the presentinvention;

FIG. 7 is a flow chart of a first portion of the compressor controllogic;

FIG. 8 is a flow chart of a second portion of the compressor controllogic;

FIG. 9 is a flow chart of a third portion of the compressor controllogic;

FIG. 10 is an exemplary graph of patient temperature and bathtemperature versus time;

FIG. 11 is a schematic diagram of an alternative heating/cooling system;

FIG. 12 is a schematic diagram of an alternative refrigerating fluidcircuit;

FIG. 13 is a side plan view of a saline pump assembly;

FIG. 14 is a top plan view of the saline pump assembly;

FIG. 15 is a top plan view of a pump support platform;

FIG. 16 is a bottom plan view of a pump;

FIG. 17 is a perspective view of an alternative saline pump assembly;

FIG. 18 is an exploded view of the alternative saline pump assembly;

FIG. 19 is a side plan view of a preferred flow detector;

FIG. 20 is flow chart of the saline flow detection logic; and

FIG. 21 is flow chart of the glycol flow detection logic.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Description of theHeating/Cooling System

Referring initially to FIG. 1, a patient heating/cooling system is shownand generally designated 10. As shown, the system 10 includes threeseparate fluid circuits: a saline circuit (also referred to as theworking fluid circuit), a water glycol circuit (also referred to as theheating/cooling fluid circuit), and a refrigerant circuit (also referredto as the refrigerating fluid circuit.)

Taking the saline circuit first, an indwelling heat exchange catheter 12that can be inserted into a patient 13 during an operation is connectedto a heat exchange bath 14 by a saline supply line 16. The supply line16 is connected to a coiled or helical heat exchange tube 17 that isimmersed in the bath 14 fluid to exchange heat therewith. In turn, theheat exchange tube 17 is connected to a peristaltic tubing saline pump18 by fluid line 20. Preferably, the saline pump 18 draws saline from asaline reservoir 22 via fluid line 24. As shown, the saline reservoir 22is disposed within a saline level detector 25 that, as described indetail below, helps control the saline pump 18 based on the level ofsaline in the level reservoir 22. It is to be understood that in apreferred embodiment, the saline pump 18 has four modes: a standby oroff mode, two treatment modes (i.e., two treatment speeds), and an idlemode wherein the saline pump 18 operates very slowly, but does not stop.In the idle mode, the patient 13 is effectively thermally decoupled fromthe heating/cooling system 10.

As further shown in FIG. 1, a saline source 26 provides saline to thesaline reservoir 22 via fluid line 28. In a preferred embodiment, thesaline source 26 is an intravenous (IV) bag and a line clamp 27 isinstalled on fluid line 28 between the saline source 26 and the salinereservoir 22. It is to be understood that after the saline reservoir 22is filled the line clamp 27 is clamped on fluid line 28 to isolate thesaline source 26 from the saline reservoir 22. FIG. 1 shows a salinereturn line 29 communicates saline from the catheter 12 to the salinereservoir 22 to complete the saline circuit. It is to be appreciatedthat the tubes 16, 17, 20, 24, and 29 can be provided as a disposable IVtubing set.

FIG. 1 also shows a system controller 30 that is connected to the salinelevel detector 25 via electrical line 32 and electrical line 34, i.e.,one for each infrared detector that is associated with the saline leveldetector 25 as described below. Preferably, the system controller 30 isalso connected to a safety switch 36 of the saline pump 18 viaelectrical line 38. As described in further detail below, the systemcontroller 30 receives signals from the saline level detector 25regarding the level of saline therein and uses this information tocontrol the saline pump 18, including opening the safety switch 36 tode-energize the saline pump 18 under certain low saline levelconditions.

It is to be understood that within the saline circuit, saline iscirculated to and from the catheter 12 through the helical heat exchangetube 17 in the heat exchange bath 14. As described in detail below, theheat exchange bath 14 is filled with heating/cooling fluid, preferablywater glycol. The water glycol can be heated or cooled in order to heator cool the saline and thus, increase or decrease the temperature of thepatient 13 into which the catheter 12 is inserted. Also, it is to beunderstood that the preferred working fluid is saline, but any similarfluid well known in the art can be used.

Now considering the water glycol circuit, the water glycol circuitcommunicates with a chiller/heater 40 via a water glycol supply line 42and a water glycol return line 44. A water glycol pump 46 is installedin the water glycol return line 44 to circulate water glycol through thewater glycol circuit. FIG. 1 shows that the heat exchange bath 14 isalso in fluid communication with a water glycol reservoir 47 installedwithin a water glycol level detector 48 via fluid line 50. In accordancewith principles described below, the water glycol level detector 48 isused to determine the level of water glycol within the heat exchangebath 14.

Further, the system controller 30 is connected to the chiller/heater 40via electrical lines 52 and 54. Moreover, the system controller 30 isconnected to a safety switch 55 at the water glycol pump 46 viaelectrical line 56 and to the coolant level detector 48 via electricalline 58 and electrical line 60. Thus, the system controller 30 cancontrol the operation of the chiller/heater 40 based on signals from atemperature monitor, described below, and control the operation of thewater glycol pump 46 based on level signals from infrared detectors,also described below, that are disposed within the water glycol leveldetector 48. As shown, the system controller 300 is also connected to atemperature sensor 57 placed at the outlet of the chiller/heater viaelectrical line 59. The controller 30 uses input from the temperaturesensor 57 to control the chiller/heater 40 and other system 10components.

It is to be understood that as the water glycol is pumped through thewater/glycol circuit the chiller/heater 40 can heat or cool the waterglycol. Within the heat exchange bath 14, the water glycol exchangesheat with the saline. Thus, the water glycol can be used to heat or coolsaline and in turn, heat or cool the patient in which the catheter 12 isintubated. It is to be further understood that water glycol is thepreferred heating/cooling fluid. However, any other fluid with similarproperties can be used.

Now considering the third (refrigerant) circuit, a variable speed directcurrent (DC) compressor 62 is in fluid communication with thechiller/heater 40 via a refrigerant supply line 64 and a refrigerantreturn line 66. It is to be understood that the compressor 62 is filledwith refrigerant, e.g., R134a. A compressor controller 68 is connectedto the compressor 62 via an electrical line 70. In turn, the systemcontroller 30 is connected to the compressor controller 68 viaelectrical line 72. The compressor controller 68 is also connected to aheater, described below, within the chiller/heater 40 via electricalline 73.

It is to be understood that the system controller 30 receivestemperature signals from the temperature monitor, described below, anduses these signals to control the operation of the compressor 62 and theheater. The compressor 62 is used to cool the water glycol that ispumped through the chiller/heater 40 by the water glycol pump 46.

Continuing to refer to FIG. 1, a DC power supply 74 is connected to thesystem controller 30 by an electrical line 76. In turn, the DC powersupply 74 preferably is connected to an isolation transformer (XFMR) 78by electrical line 80. The XFMR 78 can be connected to an alternatingcurrent (AC) input 82, e.g., a standard one hundred and twenty volt(120V) wall outlet, via a power cord 84. The system 10 can also beconfigured to work accommodate one hundred to two hundred and fortyvolts AC (100-240 VAC).

As further shown in FIG. 1, a temperature monitor 86 is connected to thesystem controller 30 via an electrical line 88. A first patienttemperature probe 90 and a second patient temperature probe 92preferably are connected to the temperature monitor 86 via electricallines 94 and 96, respectively. As intended herein, the temperaturemonitor 86 uses the temperature probes 90, 92 to monitor the temperatureof the patient 13. Moreover, the temperature monitor 86 sends signals tothe system controller 30 representing the temperature of the patient 13.These signals are used by the system controller 30 to control theoperation of the chiller/heater 40, the saline pump 18, and the DCcompressor 62.

FIG. 1 shows a display device 98 that is connected to the systemcontroller 30 via electrical line 100 and electrical line 102.Preferably, the display device 98 provides a visual indication of thepatient's temperature and the bath temperature. For example, the displaydevice 98 can be used to output graphs of minute by minute patienttemperature (for, e.g., twenty one days) and water glycol bathtemperature. the display device 98 can also be used to provideinformation regarding the cooling power required by the patient, whetherthe system is heating or cooling the bath, and at which rate, e.g., low,medium, or maximum, the system is heating or cooling the bath. Further,the display device 98 can display the current patient temperature andthe patient target temperature.

It is to be understood that a user can scroll the graphs left or rightwith respect to a stationary cursor within the center of the display. Asthe graphs are scrolled, information corresponding thereto can bedisplayed. As shown, the display device 98 also includes a control panel104 to allow a user, i.e., a doctor or a nurse, to input data, such as atarget patient temperature, to the system 10.

Description of the Heat Exchange Bath

Referring now to FIG. 2, details of one preferred, non-limiting heatexchange bath 14 are shown. FIG. 2 shows that the preferred heatexchange bath 14 includes a bottom 110 having a generally cylindricalcontinuous sidewall 112 extending therefrom. As shown, the bottom 110 ofthe bath 14 is formed with a hole 114 and the water glycol supply line42 is connected thereto. A preferably vertical standpipe 116 extendsfrom the end of the water glycol supply line 42 into the interior of thebath 14. In a preferred embodiment, the standpipe 116 is perforatedalong its length with a series of four hole rings 118 out of which waterglycol flows into the bath 14. These four hole rings 118 ensure radialmovement of the water glycol through the heat exchange tubing 17, i.e.,between and across the turns of the coil. It can be appreciated that inlieu of the standpipe 116, a small impeller (not shown) can be mountedon the bottom 110 of the bath 14 to circulate the water glycol therein.

As shown in FIG. 2, the generally spiral-shaped heat exchange tubing 17is disposed within the bath 14 such that when the bath 14 is filled withwater glycol the heat exchange tubing 17 is fully immersed in the waterglycol. FIG. 2 shows that the saline supply line 16 is connected to oneend of the heat exchange tubing 17. Conversely, the fluid line 20 fromthe saline pump 18 is connected to the other end of the heat exchangetubing 17. As shown, to center and support the spiral-shaped tubing set120 around the standpipe 116, four vertical stanchions 122 (only twoshown in FIG. 2) extend up from the bottom 110 of the bath 14 and touchthe outer surface of the tubing set 120. In the alternative, the heatexchange tubing 17 can rest against the sidewall 112 of the bath 14.

FIG. 2 further shows that the bath 14 is covered by a lid 124.Preferably, the bottom of the lid 124 is spaced above the top of thewater glycol within the bath 14 in order to establish a dead air space126 between the lid 124 and the water glycol. This dead air space 126acts as an insulator to minimize parasitic heat loads, control theevaporation of the water glycol, and prevent progressive overfilling ofthe bath 14 by condensation from the ambient air. Also, the lid 124 canbe sealed against the wall 112 by a resilient, preferably silicone,gasket 128.

Description of the Level Detector

Referring now to FIG. 3, details of the preferred embodiment of thesaline level detector 25 are shown. It is to be understood that thewater glycol level detector 48 operates using the same principles as thesaline level detector 25. As shown in FIG. 3, the saline level detector25 includes a housing 130 that is preferably made from acetal, e.g.,Delrin® manufactured by E.I. Dupont De Nemours & Co. of Delaware. Thehousing 130 is formed with a preferably “U” shaped central bore 132 inwhich the preferably clear saline reservoir 22 is disposed. FIG. 3 showsthat the housing is formed with a first transverse bore 134, a secondtransverse bore 136, and a third transverse bore 138 leading to thecentral bore 132.

As shown, the saline level detector 25 includes a light emitter, e.g.,an infrared light emitting diode (IR LED) 140, that is mounted in thefirst bore 134 on one side of the level detector 22. On the other hand,preferably two light detectors, such as a first IR detector 142 and asecond IR detector 144, are placed on the opposite side of the salinelevel detector 25 from the LED 140 within the second and thirdtransverse bores 136, 138. Preferably, the detectors 142, 144 arephotodiodes or phototransistors.

In the presently preferred embodiment, IR LED 140 and the IR detectors142, 144 are coplanar. Preferably, the IR LED 140 emits an IR light beamthat can be detected by the first IR detector 142 if the saline level isbelow a predetermined level, e.g., the level of the IR LED 140 and theIR detectors 142, 144. In other words, if the saline is low, the IRlight beam takes the path toward the first JR detector 142 as indicatedby the dashed line 146. Conversely, if the saline is at the proper levelwithin the saline level detector 25, the IR light beam is refracted sothat it is detected by the second IR detector 144. In this case, the IRlight beam takes the path indicated by line 148.

It is to be understood that the IR light beam can be modulated, i.e.pulsed, e.g., at nine and a half kiloHertz (9.5 kHz), to avoid falsedetections caused, e.g., by other light sources placed in the same roomas the level detector 25 and/or bubbles in the saline reservoir 22. Forthis purpose, the first IR detector 142 and second IR detector 144 canbe connected to upper and lower tone detectors 150, 152, respectively,which output signals only when they receive an input of, e.g., 9.5 kHz.It can be appreciated that when the saline level within the leveldetector falls below a predetermined level, the controller 30 canactivate an alarm at the display device 98. The alarm can include avisible alarm, e.g., a light, or an audible alarm, e.g., a buzzer.Moreover, when the saline level drops below the predetermined level thecontroller 30 can de-energize the saline pump 18 by opening the safetyswitch 36.

Description of the Chiller/Heater

FIG. 4 shows the details regarding one preferred, non-limitingimplementation of the chiller/heater 40. As shown in FIG. 4, thechiller/heater 40 is a shell-and-tube heat exchanger having a lowerchamber 160, an upper chamber 162, and plural tubes 164 communicatingwater glycol therebetween. It is to be understood that water glycolflows into the lower chamber 160, up the tubes 164, into to the upperchamber 162, and out of the upper chamber 162 to the heat exchange bath14. Refrigerant, e.g., R134a, flows around the tubes 164 to cool thewater glycol therein. A resistive heater element 166 is disposed in thelower chamber 160 and extends partially up an enlarged center tube 168for heating the water glycol in the chiller/heater 60. As shown, theheater element 166 can include a built-in thermocouple temperaturesensor 170 that can be used as described in detail below to determine ifglycol is flowing through the chiller/heater 60. It is to be appreciatedthat in a less preferred embodiment the chiller/heater 40 and the heatexchange bath 14 can be combined into a single unit. Moreover, it is tobe appreciated that the temperature sensor 170 can be connected to thesystem controller.

Description of the Overall Operation Logic of the Present Invention

Referring now to FIG. 5, the overall operation logic of the presentinvention is shown and commences at block 200 wherein the controller 30is initialized and the patient temperature (T_(pt)), the patient targettemperature (T_(target)), and the bath temperature (T_(bath)) arereceived. Preferably, T_(pt) is received from the temperature monitor86, specifically from the second temperature probe 92. Moving to block202, a temperature differential, ΔT, is determined by subtracting T_(pt)from T_(target). Next, at decision diamond 204 it is determined whetherthe absolute value of ΔT is less than a predetermined amount, e.g., onetenth of a degree Celsius (0.1° C.).

If the absolute value of ΔT is greater than 0.1° C., the logic moves toblock 206 where the system 10 enters maximum cooling mode or maximumwarming mode. It is to be understood that if ΔT is negative the salinepump 18 is brought to full speed, the compressor 62 is turned on at highspeed, and the heater 166 is turned off to cool the patient. Conversely,if ΔT is positive, the saline pump 18 is brought to full speed, thecompressor 62 is turned off, and the heater 166 is turned on to warm thepatient.

Returning to decision diamond 204, if the absolute value of ΔT is lessthan 0.1° C., the logic moves to block 208 where the rate of change ofT_(pt) with respect to time, dT_(pt)/dt, is determined using thefollowing equation:

$\left\lbrack {{\sum\limits_{i = 1}^{n}\left( \frac{n + 1}{2} \right)} - {i*{T_{p\; t}(i)}}} \right\rbrack/\left\lbrack {n*\left( \frac{1 - n^{2}}{12} \right)} \right\rbrack$

-   -   where,        -   n=10 unless there has not yet been 10 minutes worth of            patient temperature data        -   T_(pt)=Patient temperature

From block 208, the logic moves to decision diamond 210 where it isdetermined whether the absolute value of dT_(pt)/dt is greater thanthirty six hundredths of a degree Celsius per hour (0.36° C./hr). Ifnot, the logic continues to block 212 and a new T_(bath) is determined.The new T_(bath) is determined based on the rate of change of patienttemperature. A higher rate of change results in a new T_(bath) that isfurther away from the current T_(bath) and a lower rate of changeresults in a new T_(bath) that is closer to the current T_(bath). IfdT_(pt)/dt is indeed greater than 0.36° C./hr and negative, meaning thatthe patient 13 is being rapidly cooled and does not require salinecirculation through the catheter, the logic moves to block 214 where thesaline pump 18 is idled. Thereafter, the logic moves to 212 and a newT_(bath) is determined.

After block 212, the logic proceeds to block 216, wherein the compressor62 and chiller/heater 40 are operated in accordance with the rules setforth below to achieve the new T_(bath). Continuing to block 218, in apreferred embodiment, the saline pump 18 is selectively idled per thefollowing rules:

-   -   1. Condition: A warming treatment has just started and the water        glycol temperature is lower than T_(pt).        -   Rule: The saline pump 18 idled until the water glycol            temperature is at least as warm as T_(pt).    -   2. Condition: A controlled heating/cooling rate treatment has        just started and the water glycol temperature is not within one        degree Celsius (1° C.) of the water glycol reference        temperature, T_(ref), (T_(pt)−6° C. when cooling, T_(pt)+1° C.        when heating).        -   Rule: The saline pump 18 is idled until the water glycol            temperature is within 1° C. of T_(ref).    -   3. Condition: T_(pt) is within 0.1° C. of T_(target) and        dT_(pt)/dt<0.36° C./hr.        -   Rule: The saline pump 18 is idled at a very low rate until            the water glycol temperature reaches T_(ref).    -   4. Condition: PID has been controlling the system, the error        exceeds the overshoot threshold, and the water glycol        temperature is warmer than T_(pt).        -   Rule: The saline pump 18 is idled until the water glycol            temperature is lower than T_(pt).    -   5. Condition: PID has been controlling the system, the error        exceeds the undershoot threshold, and the water glycol        temperature is cooler than T_(pt).        -   Rule: The saline pump 18 is idled until the water glycol            temperature is higher than T_(pt).

After the saline pump 18 is selectively idled as described above, thelogic proceeds to block 220 where the system enters the linear coolingmode, described below.

Description of the Linear Mode Operation Logic of the Present Invention

FIG. 6 shows the linear mode operation logic of the present invention.Commencing at block 230 a do loop is entered wherein while in the linearmode, the succeeding steps are performed. In the linear mode, several“fail safe” tests are monitored for to revert to maximum cooling orheating in the event that a rapid patient temperature change occurs. Forinstance, at decision diamond 232, if it is determined that ΔT isgreater than one half a degree Celsius (0.5° C.) and has a negativesign, the system exits linear mode and enters maximum cooling mode atblock 234. Also, if at decision diamond 236 it is determined that ΔT ispositive and greater than three tenths of a degree Celsius (0.3° C.),the logic moves to block 238 where the linear mode is exited and themaximum warming mode is entered. Moreover, at block 240, dT_(pt)/dt isdetermined using the equation described above.

Proceeding to decision diamond 242, it is determined whether dT_(pt)/dtis greater than seven tenths of a degree Celsius per hour (0.7° C./hr)for the last ten (10) minutes. If so, the logic moves to block 234 wherethe linear mode is exited and the maximum cooling mode is entered. IfdT_(pt)/dt is less than 0.7° C./hr for the last 10 minutes, the logicreturns to decision diamond 232 and continues as described above.

Description of the Compressor Control Logic of the Present Invention

Referring now to FIG. 7, the control logic of the compressor is shownand commences at block 250 with a do loop, wherein after a new T_(bath)is determined, the following steps are performed. At decision diamond252, it is determined whether the new T_(bath) is greater than thecurrent T_(bath). If the new T_(bath) is lower than the currentT_(bath), the logic moves to block 254 and the heater 166 is deactivatedwhile the compressor 62 is activated at maximum speed to cool the waterglycol.

Continuing to decision diamond 256, it is determined whether the currentbath temperature is within a predetermined range, e.g., two-tenthsdegrees Celsius (0.2° C.) of the new T_(bath). If not, the logic movesto block 258 where the cooling of the water glycol is continued. Thelogic then returns to decision diamond 256. If the current bathtemperature is within the predetermined range of the new T_(bath), thelogic moves to block 260 wherein the compressor speed is progressivelyreduced.

From block 260, the logic moves to decision diamond 262 where it isdetermined whether the current temperature is stable at the newT_(bath). If so, the logic moves to block 264 and the compressor 62 isheld at the current speed to maintain the temperature at the newT_(bath). If, at decision diamond 262, the temperature has notstabilized at the new T_(bath), the logic moves to decision diamond 266where it is determined whether the minimum compressor speed has beenreached. If the minimum compressor speed has not been reached, the logicreturns to block 260 and continues as described above. Conversely, ifthe minimum compressor speed has been reached, the logic moves to block268 where the heater power is progressively increased.

Next, the logic continues to decision diamond 270 where it is determinedif the current temperature has stabilized at the new T_(bath). If not,the logic returns to block 268 where the heater power continues to beprogressively increased. If, on the other hand, the current temperaturehas stabilized at T_(bath) the logic moves to block 272 where thecurrent power is maintained. Thereafter, the logic moves to block 264where the compressor is idled at the current speed, in this case thelowest speed, in order to maintain the temperature at T_(bath). In apreferred, non-limiting embodiment, the lowest temperature to which thebath can be commanded is one-half degree Celsius (0.5° C.).

Returning to decision diamond 252, if the new T_(bath) is greater thanthe current temperature, the logic proceeds to decision diamond 274where it is determined whether the new T_(bath) is less than or equal toa predetermined upper bath limit, e.g., forty two degrees Celsius (42°C.). If the new T_(bath) is less than the upper bath limit, the logicmoves to FIG. 8. However, if the new T_(bath) is equal to the upper bathlimit, the logic moves to FIG. 9.

Proceeding to FIG. 8, if the new T_(bath) is less than the upper bathlimit, the logic proceeds to block 276 where the compressor 62 isactivated at minimum speed and the heater 166 is activated at maximumpower. From block 276, the logic moves to decision diamond 278 where itis determined if the current temperature is within a predeterminedrange, e.g., two-tenths degrees Celsius (0.2° C.) of the new T_(bath).If not, the logic proceeds to block 280 and the heating of the waterglycol is continued. If the temperature is within the predeterminedrange, the logic continues to block 282 where the heater power isprogressively reduced.

Next, at decision diamond 284, it is determined whether the currenttemperature has stabilized at the new T_(bath). If the currenttemperature has stabilized at the new T_(bath), the current heater poweris maintained to maintain the temperature at the new T_(bath). On theother hand, if the current temperature has not stabilized, the logicproceeds to decision diamond 288 where it is determined if the heaterduty cycle is equal to zero (0). If not, the logic returns to block 282where the progressive reduction of the heater power is continued.

If, at decision diamond 288, the heater duty cycle is equal to zero,indicating that the lowest heating power has been reached, logiccontinues to block 290 where the speed of the compressor 62 isprogressively increased. Thereafter, at decision diamond 292, it isdetermined whether the current temperature has stabilized at the newT_(bath). If the temperature has not stabilized, the logic moves toblock 290 where the reduction of the compressor speed is continued. Onthe other hand, if the temperature of the compressor speed hasstabilized at T_(bath), the logic continues to block 294 where thecurrent compressor speed is maintained. The logic then moves to block286 and ends.

Returning to decision diamond 274 (FIG. 7), if the new T_(bath) is equalto the upper bath limit, the logic moves to FIG. 9. At block 296, thecompressor is deactivated and the heater is activated at maximum power.From block 296, the logic moves to decision diamond 298 where it isdetermined whether the temperature is within a predetermined range,e.g., two-tenths degrees Celsius (0.2° C.), of the new T_(bath). If not,the heating of the water glycol is continued at block 300. If thecurrent temperature is within 3° C. of the new T_(bath), the logicproceeds to block 302 where the power of the heater 166 is progressivelyreduced. Then, at decision diamond 304, it is determined whether thetemperature has stabilized at the new T_(bath). If so, the currentheater power is maintained to maintain the temperature at the newT_(bath). Conversely, if the temperature has not stabilized at the newT_(bath), the logic continues to decision diamond 308 where it isdetermined whether the heater duty cycle has reached zero (0). If theheater duty cycle has not reached zero, the logic returns to block 302where the progressive reduction of the heater power is continued. On theother hand, if the heater duty cycle has reached zero, the compressor 62is briefly cycled in order to cool the water glycol. Next, at decisiondiamond 312, it is again determined whether the temperature hasstabilized at the new T_(bath). If not, the logic returns to block 310and the compressor is again briefly cycled to cool the water glycol. If,at decision diamond 312, the temperature has stabilized at the newT_(bath), the logic moves to block 306 and ends.

It is to be understood that the system described above has two nestedclosed-loop controllers: an outer loop and an inner loop. The outer loopis directly responsible for controlling the patient temperature and isdriven by the temperature difference between T_(target) and T_(pt). Onthe other hand, the inner loop is directly responsible for the coolanttemperature, i.e., T_(bath), that is established by the systemcontroller 30. It is further to be understood that the outer loop logic,i.e., the overall operation logic and linear mode operation logicdescribe above, resides in the system controller 30. The inner loopcontrol logic, i.e., the compressor control logic described above,resides in the compressor controller 68. As intended by the presentinvention, when the compressor controller 68 receives a command toestablish a new T_(bath), the compressor controller 68 controls thecompressor 62 and the heater 166, as described above, in order toachieve the new T_(bath).

In a preferred, non-limiting embodiment, the compressor controller 68has two means of control over the compressor 62. First, it can turn thepower to compressor 62 on and off via a solid-state DC relay. Second, itcan modulate the compressor speed between a maximum value, e.g., thirtyfive hundred revolutions per minute (3,500 RPM), and a minimum value,e.g., two thousand revolutions per minute (2,000 RPM).

Also, in a non-limiting embodiment, the compressor controller 68 hasonly duty-cycle control over the heater 166. The compressor controller68 can modulate the heater power anywhere between zero percent (0%),i.e., off, and one hundred percent (100%), i.e., on. Preferably, theheater 166 has a fixed one second (1 s) pulse period. Also, in apreferred embodiment the heater 166 has a maximum power of two hundredand forty watts (240 w). Thus, a fifty percent (50%) duty cyclecorresponds to one hundred and twenty watts (120 w) of time-averagedinput power to the water glycol and a twenty five percent (25%) dutycycle would correspond to sixty watts (60 w) of time-averaged inputpower.

Description of an Exemplary Graph of Patient Temperature and BathTemperature Versus Time

FIG. 10 shows one exemplary, non-limiting graph of T_(pt), representedby line 320, and T_(bath), represented by line 322, plotted versus time.As shown, the patient is initially in a hyperthermic state, i.e., thepatient has a fever of thirty-nine degrees Celsius (39° C.). The patientis cooled from 39° C. toward a T_(target) equal to thirty-six andone-half degrees Celsius (36.5° C.) preferably over a three hour periodat a rate of eight tenths of a degree Celsius per hour (0.80° C./hr).This can be achieved by entering a maximum cooling mode where theT_(bath) is one-half a degree Celsius (0.5° C.).

Once T_(pt) reaches thirty six and six tenth degrees (36.6° C.), thesaline pump 18 preferably is idled to thermally de-couple the patient 13from the cooling system 10 and the T_(bath) is increased, e.g., byenergizing the heater 166, to approximately twenty-five degrees Celsius(25° C.). By thermally de-coupling the patient 13 from the coolingsystem 10, T_(pt) will discontinue the rapid decrease described abovewhile T_(bath) is increased.

After T_(bath) reaches 25° C., the saline pump 18 is returned to fullspeed to thermally couple the patient 13 to the cooling system 20. Asintended by the present invention, the higher T_(bath) slows the rate atwhich the patient 13 is cooled and helps to maintain T_(pt) in a stateof equilibrium near T_(target), e.g., within one-tenth of a degreeCelsius (0.1° C.) of T_(target). If necessary, T_(bath) can be slightlyincreased or decreased, e.g., less than five degrees Celsius (5° C.), asshown in order to maintain T_(pt) in the state of equilibrium describedabove.

Description of an Alternative Heating/Cooling System

Referring now to FIG. 11, an alternative patient heating/cooling systemis shown and generally designated 410. Similar to the above-describedsystem 10, the system 410 shown in FIG. 11 includes three separate fluidcircuits: a saline circuit (also referred to as the working fluidcircuit), a water glycol circuit (also referred to as theheating/cooling fluid circuit), and a refrigerant circuit (also referredto as the refrigerating fluid circuit.)

Taking the saline circuit first, an indwelling heat exchange catheter412 that can be inserted into a patient 413 during an operation isconnected to a heat exchange bath 414 by a saline supply line 416. Thesupply line 416 is connected to a coiled or helical heat exchange tube417 that is immersed in the bath fluid to exchange heat therewith. Inturn, the heat exchange tube 417 is connected an air trap vessel 418 byfluid line 420. The air trap vessel 418 is surrounded by an air trapdetector 419. As shown, the air trap vessel 418 is connected to a salinepump 422 by fluid line 424.

It is to be understood that the air trap detector 419 is identical inconstruction to the saline level detector 25 described above and shownin FIG. 3 and can be used to detect when air is introduced into theworking fluid circuit downstream from the pump 422, e.g., by the pump422 itself. Accordingly, if air is detected in the air trap vessel 418,the pump 422 is immediately shut down by a controller in accordance withthe principles discussed earlier.

As further shown in FIG. 11, a saline source 426 provides saline to thepump 422 via fluid line 427. FIG. 11 shows a saline return line 428 thatcommunicates saline from the catheter 412 to the saline, reservoir 426to complete the saline circuit. A saline flow detector 429, described indetail below, is installed along the saline return line 428 between thecatheter 412 and the saline reservoir 426. FIG. 11, shows that thesaline flow detector 429 provides feedback to the system controller,described below, via electrical line 425.

FIG. 11 also shows a system controller 430 that is connected to the airtrap detector 419 via electrical line 432 and electrical line 434, i.e.,one for each infrared detector that is associated with the air trapdetector 419. Preferably, the system controller 430 is also connected toa safety switch 436 of the saline pump 422 via electrical line 438. Asdescribed in further detail below, the system controller 430 receivessignals from the air trap detector 419 regarding the level of salinetherein and uses this information to control the saline pump 422,including opening the safety switch 436 to de-energize the saline pump422 under certain low saline level conditions. It is to be understoodthat within the saline circuit, saline is circulated to and from thecatheter 412 through the helical heat exchange tube 417 in the heatexchange bath 414.

Now considering the water glycol circuit, the water glycol circuitcommunicates with a chiller/heater 440 via a water glycol supply line442 and a water glycol return line 444. A water glycol pump 446 isinstalled in the water glycol supply line 442 to circulate water glycolthrough the water glycol circuit. FIG. 11 shows that the heat exchangebath 414 is also in fluid communication with a water glycol reservoir447 via fluid line 450. As shown, the water glycol reservoir isinstalled within a water glycol level detector 448. In accordance withthe principles described above, the water glycol level detector 448 canbe used to determine the level of water glycol within the heat exchangebath 414.

Further, the system controller 430 is connected to the chiller/heater440 via electrical lines 452 and 454. Moreover, the system controller430 is connected to the coolant level detector 448 via electrical line458 and electrical line 460. Thus, the system controller 430 can controlthe operation of the chiller/heater 440 based on signals from atemperature monitor, described below, and control the operation of thewater glycol pump 446 based on level signals from the infrared detectorsthat are disposed within the water glycol level detector 448. As shown,the system controller 430 is also connected to a temperature sensor 457placed at the outlet of the chiller/heater via electrical line 459. Thecontroller 430 uses input from the temperature sensor 457 to control thechiller/heater 440 and other system 410 components.

It is to be understood that as the water glycol is pumped through thewater/glycol circuit the chiller/heater 440 can heat or cool the waterglycol. Within the heat exchange bath 414, the water glycol exchangesheat with the saline. Thus, the water glycol can be used to heat or coolsaline and in turn, heat or cool the patient in which the catheter 412is installed. It is to be further understood that water glycol is thepreferred heating/cooling fluid. However, any other fluid with similarproperties can be used.

Now considering the third (refrigerant) circuit, a variable speed directcurrent (DC) compressor 462 is in fluid communication with thechiller/heater 440 via a refrigerant supply line 464 and a refrigerantreturn line 466. It is to be understood that the compressor 462 isfilled with refrigerant, e.g., R134a. A compressor controller 468 isconnected to the compressor 462 via an electrical line 470. In turn, thesystem controller 430 is connected to the compressor controller 468 viaelectrical line 472. The compressor controller 468 is also connected toa heater (FIG. 4) within the chiller/heater 440 via electrical line 473.

It is to be understood that the system controller 430 receivestemperature signals from the temperature monitor, described below, anduses these signals to control the operation of the compressor 462 andthe heater. The compressor 462 is used to cool the water glycol that ispumped through the chiller/heater 440 by the water glycol pump 446.

Continuing to refer to FIG. 11, a DC power supply 474 is connected tothe system controller 430 by an electrical line 476. In turn, the DCpower supply 474 preferably is connected to an isolation transformer(XFMR) 478 by electrical line 480. The XFMR 478 can be connected to analternating current (AC) input 482, e.g., a standard one hundred andtwenty volt (120V) wall outlet, via a power cord 484. It can beappreciated that a power supply having a low current leakage can be usedand if it is indeed used, the XFMR 478 can be eliminated.

As further shown in FIG. 11, a temperature monitor 486 is connected tothe system controller 430 via an electrical line 488. A first patienttemperature probe 490 and a second patient temperature probe 492preferably are connected to the temperature monitor 486 via electricallines 494 and 496, respectively. As intended herein, the temperaturemonitor 486 uses the temperature probes 490, 492 to monitor thetemperature of the patient 413. Moreover, the temperature monitor 486sends signals to the system controller 430 representing the temperatureof the patient 413. These signals are used by the system controller 430to control the operation of the chiller/heater 440, the saline pump 418,and the DC compressor 462.

FIG. 11 shows a display device 498 that is connected to the systemcontroller 430 via electrical line 500 and electrical line 502.Preferably, the display device 498 can provide a visual indication ofthe patient's temperature and the bath temperature. For example, thedisplay device 498 can be used to output graphs of minute by minutepatient temperature (for, e.g., twenty one days) and water glycol bathtemperature. The display device 498 can also be used to provideinformation regarding the cooling power required by the patient, whetherthe system is heating or cooling the bath, and at which rate, e.g., low,medium, or maximum, the system is heating or cooling the bath. Further,the display device 498 can display the current patient temperature andthe patient target temperature.

It is to be understood that a user can scroll the graphs left or rightwith respect to a stationary cursor within the center of the display. Asthe graphs are scrolled, information corresponding thereto can bedisplayed. As shown, the display device 498 also includes a controlpanel 504 to allow a user, i.e., a doctor or a nurse, to input data,such as a target patient temperature, to the system 410.

Description of an Alternative Refrigerating Fluid Circuit

Referring to FIG. 12 an alternative refrigerating fluid circuit is shownand is generally designated 600. FIG. 12 shows that the refrigeratingfluid circuit 600 includes a first compressor 602 and a secondcompressor 604 that are connected in parallel to each other andconnected in series to a condenser 606 and an evaporator 608. Anexpansion valve 610 is also connected between the condenser 606 and theevaporator 608 to complete the fluid circuit. As shown in FIG. 12,glycol is pumped to and from the evaporator 608 from a glycol bath. In apreferred embodiment, the compressors 602, 604 are variable speed directcurrent (dc) compressors that can be controlled by a controller, e.g., acomputer or any other microprocessor. In order to prevent one or both ofthe compressors 602, 604 from stalling during operation, the controllerpreferably includes an algorithm that can prevent either compressor frombeing energized when the other compressor is fully loaded. It can beappreciated that the two compressors 602, 604 working in parallel witheach other increase the cooling power of the refrigerating fluid circuit600.

Description of a Saline Pump Assembly

FIGS. 13 and 14 show an exemplary, non-limiting saline pump assembly,generally designated 650. As shown in FIGS. 13 and 14, the pump assembly650 includes a diaphragm pump 652 that is removably engaged with a pumpsupport platform 654. In one non-limiting embodiment, the pump 652 issimilar to the high efficiency diaphragm pump disclosed in U.S. Pat.Nos. 5,791,882 and 5,800,136, incorporated herein by reference.

FIG. 13 shows that the pump support platform 654 includes an upper plate656 and a lower plate 658 that, in a preferred embodiment, are attachedto each other, e.g., by threaded fasteners. As shown in FIG. 13, pluralfeet 660 extend from the lower plate 658 and provide stable support forthe pump support platform 654. FIG. 13 also shows that a pump driveassembly 662 is incorporated into the lower plate 658 of the pumpsupport platform 654. The pump drive assembly 662 includes a motor and adrive shaft, described below, that extends through the upper plate 656of the pump support platform 654 and engages the pump 650.

As shown in FIGS. 13 and 14, the pump support platform 654 includes aquick-release locking arm 664 that prevents the pump 652 from beingdisengaged with the pump support platform 654—unless the locking arm 664is rotated to release the pump 652. FIGS. 14 and 15 also show that thepump support platform 654 includes an overflow bore 665 through whichany saline that may leak from the pump 652 can flow. FIG. 14 furthershows that the pump 652 includes an inlet 666 and an outlet 668. Asdiscussed above, the pump 652, i.e., the outlet 668 thereof, can beconnected to the air trap vessel 418 (FIG. 11) that is downstream fromthe pump 652.

Referring now to FIG. 15, further details concerning the pump supportplatform 654 are shown. FIG. 15 shows that the upper plate 656 of thepump support platform 654 is formed with a generally cylindrical pumplocking bore 672. The outer periphery of the pump locking bore 672 isradially formed with a first, slot 674, a second slot 676, and a thirdslot 678. As shown, each slot 674, 676, 678 is equally spaced around theouter periphery of the pump locking bore 672. Also, each slot 674, 676,678 is curved to match the radius of curvature of the pump locking bore672 and each slot 674, 676, 678 terminates in a semi-cylindrical bay680, 682, 684. FIG. 15 also shows that a drive shaft 686 extends fromthe pump drive assembly 662 (FIG. 13) through the upper plate 656. It isto be understood that the pump drive assembly 662 includes a motor 687for rotating the drive shaft 686. The motor 687 can be directlyconnected to the drive shaft 686, as shown, or it can be geared thereto.

FIG. 16 shows further details concerning the construction of the pump652. As shown, the pump 652 includes a generally cylindrical lowerhousing 688. A first generally cylindrical leg 690, a second generallycylindrical leg 692, and a third generally cylindrical leg 694 areequally spaced around the periphery of the lower housing 688. FIG. 16shows that the pump 652 further includes a drive shaft receptacle 696into which the drive shaft 686 (FIG. 15) extends when the pump 652 isremovably engaged with the pump support platform 654. It is to beunderstood that the drive shaft 686 is keyed to the drive shaftreceptacle 696.

It can be appreciated that the pump 652 can be engaged with the pumpsupport platform 654 by aligning the cylindrical legs 690, 692, 694 withthe semi-cylindrical bays 680, 682, 684 established by the pump lockingbore 672. The drive shaft 686 is also aligned with the drive shaftreceptacle 696. In this relationship, the pump 652 can be slid towardthe pump support platform 654 until the lower housing 688 of the pump652 contacts the upper plate 656 of the pump support platform 654. Thepump 652 is then rotated within the pump locking bore 672 until each leg690, 692, 694 of the pump 652 reaches a respective end of each slot 674,676, 678 formed by the pump locking bore 672. It is to be understoodthat during installation of the pump 652 on the pump support platform654, one leg 690, 692, 694 of the pump 652 (any leg, thereof) ridesagainst and then past the quick-release locking arm 664 until thequick-release locking arm 664 clears the leg 690, 692, 694 and snapsunder spring bias to a position to prevent the pump 652 from beingremoved from the pump support platform 654.

In accordance with the principles of the present invention, a pump 652can be easily engaged and disengaged with the pump support platform 654during use. Thus, a first sterilized pump can be used in conjunctionwith the treatment of a first patient. After treatment has concluded,the now-used pump can be removed and replaced with a second sterilizedpump to be used in conjunction with the treatment of a second patient.The pump support platform 654 (and the motor therein) need not bereplaced for each new pump and the costs of utilizing the heat/coolingsystem of the present invention are reduced.

Description of an Alternative Saline Pump Assembly

In an alternative embodiment, as shown in FIGS. 17 and 18, a saline pumpassembly 700 includes a pump support platform 702 and a positivedisplacement gear pump 704. In non-limiting embodiments, the gear pump704 can incorporate some or all of the features set forth in U.S. Pat.Nos. 6,270,324; 6,210,138; 6,158,994; 5,494,416; 5,219,274; 5,165,868;and 4,065,235, all of which are incorporated herein by reference. Asshown in FIGS. 17 and 18, the pump support platform 702 includes a pumpdrive motor 706 that is preferably a brushless, direct current motor.

FIGS. 17 and 18 show that the pump support platform 702 includes a firstsupport collar 708 and a second support collar 710 that fit into agenerally cylindrical pump locking bore 712 formed in the supportplatform 702. Plural fasteners 714 can be used to affix the supportcollars 708, 710 to the support platform 702. It is to be understoodthat the gear pump 704 fits into the support collars, after they areinserted in the bore 712. As shown in FIG. 18, a first spring loadedball plunger 715 and a second spring loaded ball plunger 716 areprovided and can be used to removably engage the gear pump 704 with thesupport platform 702. One or more alignment pins 713 can be used toproperly align the gear pump 704 when it is engaged with the supportplatform 702. When the gear pump 704 is installed in the supportplatform 702, the ball plungers 715, 716 engage a metal flange 717around the gear pump 704 and provide a downward force on the metalflange 717 in order to keep the gear pump 704 installed in the supportplatform 702.

As shown in FIGS. 17 and 18, a first optical sensor 718 and a secondoptical sensor 719 are installed on the upper surface of the supportplatform 702 and can be used to detect the presence of the gear pump 704on the support platform 702. It is to be understood that each opticalsensor 718, 719 includes an emitter (not shown) and a detector (notshown) that are configured to transmit an optical signal toward thespace in which the gear pump 704 occupies when it is properly installedand detect reflection from the gear pump 704 when it is, indeed,properly installed.

FIG. 18 further shows that the gear pump 704 includes a cylindricalmagnet 720 that extends from the gear pump 704. It is to be understoodthat the cylindrical magnet 720 is attached to a drive shaft (not shown)within the gear pump 704 and as the cylindrical magnet 720 rotates itrotates the drive shaft. Further, the motor 706 includes a cup-shapedmagnet 722 that is sized and shaped to receive the cylindrical magnet720 and magnetically engage the cylindrical magnet 720. The cup-shapedmagnet 722 is coupled to a drive shaft (not shown) within the motor 706and the motor 706 can be energized to rotate the cup-shaped magnet 722.

With this structure, the gear pump 704 can be removably engaged with thesupport platform 702. When the gear pump 704 is engaged with the supportplatform 702, the cylindrical magnet 720 is magnetically coupled to thecup-shaped magnet 722. Accordingly, as the cup-shaped magnet 722 isrotated by the motor 706 it causes the cylindrical magnet 720 to rotateand which, in turn, causes the gear pump 704 to pump fluid therethrough.

It is to be understood that for overpressure protection, the gear pump704 includes a bypass relief valve (not shown) that opens on highpressure. In lieu of a bypass relief valve, the magnets 720, 722 can bemagnetized such that the magnetic coupling established therebetween canbe broken under conditions of overpressure. Moreover, the speed of thepump 704 can be established for the desired heat exchange rate.

Description of a Preferred Saline Flow Detector

Referring now to FIG. 19, a preferred, non-limiting embodiment of asaline flow detector is shown and generally designated 800. As shown inFIG. 19, the flow detector 800 includes a preferably clear, plastichousing 802 having an inlet 804 and an outlet 806. A lightweight,preferably plastic paddle wheel 808 is installed within the housing 802on an axle 810. FIG. 19 shows that the paddle wheel 808 includes acentral hub 812 from which preferably three opaque, plastic paddles 814extend radially (it is to be understood that each paddle 814 includes apair of opposing paddle blades). As shown, the paddles 814 arepositioned around the hub 812 approximately one-hundred and twentydegrees (120°) from each other. It can be appreciated that fluid flowingfrom the inlet 804 to the outlet 806 flows tangential to the paddlewheel 808 and causes it to spin. Moreover, three opaque walls 815 areformed around the paddle wheel 808 between alternating pairs of adjacentpaddle blades.

As shown in FIG. 19, preferably three infrared transmitter/receiverlight emitting diode (IR T/R LED) pairs 816 can be placed such that thehousing 802 is between each IR T/R LED pair 816 and each IR T/R LED pair816 can send and receive a signal through the housing 802 across thepaddle wheel 808 to detect rotation of the paddle wheel 808 when fluidflows through the housing 802. In a preferred embodiment, the IR T/R LEDpairs 816 are positioned on an imaginary circle concentric with the axle810. Moreover, the IR T/R LED pairs are arranged so that a center pair816 is aligned with the axle 810 and two side pairs 816 flank the centerpair 816. Each side pair is approximately plus-or-minus sixty-fourdegrees (±64°) from the center pair 816 on the imaginary circle. Thisarrangement insures that that regardless of the position of the pinwheel 808, one of the three signal paths established by the IR T/R LEDpairs 816 through the housing 802 is always unblocked by the paddlewheel 808.

FIG. 19 further shows that each IR T/R LED pair 816 is connected to aprocessor 818 that, in turn, is connected to a system controller 820.The processor 818 includes a program that, based on the signals receivedfrom the IR T/R LED pairs 816, allows the processor 818 to determine ifthe paddle wheel 808 is rotating and fluid is flowing through thehousing and accordingly, the working fluid circuit. If not, an alarm canbe activated.

Description of the Saline Flow Detection Logic

FIG. 20 shows the saline flow detection logic that commences at block850 wherein the flow detector 800 is energized, i.e., its power isturned on. Moving to decision diamond 852, it is determined whetherpulses are being received at the processor 818. The pulses representmotion of the paddle wheel 808, i.e., the motion of the paddles throughthe light beams established by the IR T/R LED pairs 816. If there areindeed pulses, the logic moves to decision diamond 854 where it isdetermined whether a timer has expired. If the timer has not expired,the logic loops back to decision diamond 852 and continues as describedabove. If so, the logic moves to block 856 and an “optics error” messageis presented to the user. The logic then ends at state 858.

Returning to decision diamond 852, if pulses are not present, the logicmoves to decision diamond 860 where it is determined whether all threeIR T/R LED pairs 816 are on. If so, the logic moves to decision diamond862 where it is determined if all three IR T/R LED pairs 816 areoperating properly. This can be determined, e.g., by sequentiallytoggling the IR T/R LED pairs 816 on and off. If it is determined thatthe IR T/R LED pairs 816 are not operating properly, the logic moves toblock 856 where an “optics error” message is presented to the user. Thelogic then ends at state 858. Otherwise, an “optics ok, no pinwheel”message is presented to the user. The logic then ends at state 858.

At decision diamond 860, if all three IR T/R LED pairs 816 are not on,the logic moves to decision diamond 866 where it is determined if twoout of three of the IR T/R LED pairs 816 are on. If so, the logic movesto decision diamond 868 where it is determined whether the two IR T/RLED pairs 816 are operating properly, e.g., by toggling the two IR T/RLED pairs 816 on and off. If the two IR T/R LED pairs 816 are notoperating properly, the logic moves to block 856 where an “optics error”message is presented to the user. The logic then ends at state 858.Otherwise, if the two IR T/R LED pairs 816 are operating properly, thelogic moves to decision diamond 870 where it is determined if signalpulses are present. If not, the logic moves to block 872 where a “noflow” message is presented to the user. The logic then loops back todecision diamond 870.

At decision diamond 870, if pulses are present, the logic moves todecision diamond 874 where it is determined if all three IR T/R LEDpairs 816 are operating properly. If so, an “optics ok, flow” message isindicated to the user at block 876. Otherwise, an “optics warning, flow”message is indicated to the user at block 878. From block 876 or block878, the logic moves to block 880 where it is determined if pulses arepresent. If pulses are indeed present, the logic returns to decisiondiamond 874 and continues as described above. Conversely, if pulses arenot present, the logic proceeds to block 882 where a “no flow” messageis presented to the user. The logic then ends at state 858.

Returning to decision diamond 866, if it is determined that two IR T/RLED pairs 816 are not on, the logic continues to decision diamond 884where it is determined if one IR T/R LED pair 816 is on. If not, thelogic proceeds to block 856 where an “optics error” is presented to theuser. The logic then ends at state 858. If the IR T/R LED pair 816 ison, the logic moves to decision diamond 886 where it is determinedwhether the IR T/R LED pair 816 is operational. If the IR T/R LED pair816 is not operational, the logic continues to block 856 where an“optics error” is presented to the user. The logic then ends at state858. If the IR T/R LED pair 816 is operating properly, the logic movesto decision diamond 870 and continues as described above.

With the above logic, the flow detector 800 can indicate flow throughthe working fluid circuit only if signal pulses are output by the flowdetector 800. Moreover, while the paddle wheel 808 is rotating, theprocessor 818 is constantly testing each of the IR T/R LED pairs 816 bysequentially toggling each of the IR T/R LED pairs 816 on and off andreading the signals output thereby.

Description of the Glycol Flow Detection Logic

Referring now to FIG. 21, the glycol flow detection logic is shown andcommences at block 900 with a do loop wherein periodically, thefollowing steps are performed. At block 902, the heater 166 (FIG. 4) isperiodically pulsed. Moving to decision diamond 904, it is determined ifthere is a sudden increase in temperature (e.g., above a predeterminedquantity), as indicated by the thermocouple temperature sensor 170 (FIG.4). If not, the logic ends at state 906. Otherwise, the logic proceedsto block 908 where it is indicated to a controller that there is aproblem with the glycol circulation. It can be appreciated that inresponse to the indication of a problem, the controller can shut offpower to the heater at block 910.

Relevant Equations

As described above, the power required to cool the patient can be viewedat the display device 98. It is to be understood that the power equationdescribed below is most accurate for a patient having a weight ofapproximately seventy-five kilograms (75 kg). Accordingly, the powerused to cool a patient can be determined using the following equation:

$\left( \frac{{{t_{p\; t}}/{{t{^\circ}}}}\mspace{14mu} {C.\text{/}}\min \times 60\mspace{14mu} \min \text{/}{hr}}{1.4{^\circ}\mspace{14mu} {C.\text{/}}{hr}} \right) \times 100w \times \left( {- 1} \right)$

-   -   where:        -   dT_(pt)/dt is determined by the equation disclosed above.

While the particular HEATING/COOLING SYSTEM FOR INDWELLING HEAT EXCHANGECATHETER as herein shown and described in detail is fully capable ofattaining the above-described aspects of the invention, it is to beunderstood that it is the presently preferred embodiment of the presentinvention and thus, is representative of the subject matter which isbroadly contemplated by the present invention, that the scope of thepresent invention fully encompasses other embodiments which may becomeobvious to those skilled in the art, and that the scope of the presentinvention is accordingly to be limited by nothing other than theappended claims, in which reference to an element in the singular is notintended to mean “one and only one” unless explicitly so stated, butrather “one or more.” All structural and functional equivalents to theelements of the above-described preferred embodiment that are known orlater come to be known to those of ordinary skill in the art areexpressly incorporated herein by reference and are intended to beencompassed by the present claims. Moreover, it is not necessary for adevice or method to address each and every problem sought to be solvedby the present invention, for it is to be encompassed by the presentclaims. Furthermore, no element, component, or method step in thepresent disclosure is intended to be dedicated to the public regardlessof whether the element, component, or method step is explicitly recitedin the claims. No claim element herein is to be construed under theprovisions of 35 U.S.C. section 112, sixth paragraph, unless the elementis expressly recited using the phrase “means for.”

We claim:
 1. A heat exchange system for a heat exchange catheter,comprising: a heat exchange receptacle configured to receive a conduitcarrying fluid to and from the catheter when the fluid is at atemperature different from normal mammal body temperature to exchangeheat with a mammal in whom the catheter is disposed; and a pump incommunication with the conduit for pumping the working fluid to and fromthe catheter.
 2. The system of claim 1, wherein the pump is detachablyengaged with the conduit and a pump support platform.
 3. The system ofclaim 2, wherein the pump support platform comprises: a pump lockingbore, the pump removably engaging the pump locking bore.
 4. The systemof claim 3, wherein the pump support platform further comprises: atleast one spring loaded ball plunger, the spring loaded ball plungerremovably engaging the pump with the pump support platform.
 5. Thesystem of claim 4, wherein the pump support platform further comprises:a motor, the motor engaging the pump to provide power to the pump whenthe pump is engaged with the pump support platform.
 6. The system ofclaim 4, wherein the pump support platform further comprises: at leastone sensor for detecting the presence of the pump when it is engagedwith the pump support platform.
 7. The system of claim 1, furthercomprising: at least one air trap vessel downstream from the pump; andat least one air trap detector at least partially surrounding the airtrap vessel. 8-22. (canceled)
 23. A system for a heat exchange catheter,comprising: a heat exchange receptacle configured to receive a conduitcarrying fluid to and from the catheter when the fluid is at atemperature different from normal human body temperature to exchangeheat with a patient in whom the catheter is disposed; and a pump supportplatform supporting a pump for pumping fluid to the catheter, the pumpsupport platform further comprising at least one sensor for detectingthe presence of the pump when the pump is engaged with the pump supportplatform.
 24. The system of claim 23, wherein the pump is a gear pump incommunication with the conduit for pumping the fluid to and from thecatheter.
 25. The system of claim 23, wherein the pump is detachablyengaged with the conduit and a pump support platform.
 26. The system ofclaim 25, wherein the pump support platform comprises: a pump lockingbore, the pump removably engaging the pump locking bore.
 27. The systemof claim 26, wherein the pump support platform further comprises: atleast one spring loaded ball plunger, the spring loaded ball plungerremovably engaging the pump with the pump support platform.
 28. Thesystem of claim 27, wherein the pump support platform further comprises:a motor, the motor engaging the pump to provide power to the pump whenthe pump is engaged with the pump support platform.
 29. The system ofclaim 23, further comprising: at least one air trap vessel downstreamfrom the pump; and at least one air trap detector at least partiallysurrounding the air trap vessel.
 30. A system for a heat exchangecatheter, comprising: a heat exchange receptacle configured to receive aconduit carrying fluid to and from the catheter when the fluid is at atemperature different from normal human body temperature to exchangeheat with a patient in whom the catheter is disposed; a pump supportplatform supporting a pump for pumping working fluid to the catheter; atleast one air trap vessel downstream from the pump; and at least one airtrap detector at least partially surrounding the air trap vessel. 31.The system of claim 30, wherein the pump is a gear pump in communicationwith the conduit for pumping the fluid to and from the catheter.
 32. Thesystem of claim 30, wherein the pump is detachably engaged with theconduit and a pump support platform.
 33. The system of claim 32, whereinthe pump support platform comprises: a pump locking bore, the pumpremovably engaging the pump locking bore.
 34. The system of claim 33,wherein the pump support platform further comprises: at least one springloaded ball plunger, the spring loaded ball plunger removably engagingthe pump with the pump support platform.
 35. The system of claim 34,wherein the pump support platform further comprises: a motor, the motorengaging the pump to provide power to the pump when the pump is engagedwith the pump support platform.
 36. The system of claim 30, wherein thepump support platform further comprises at least one sensor fordetecting the presence of the pump when it is engaged with the pumpsupport platform.